Transcription of (May 2016) 3 DRAFT FOR COMMENTS - WHO
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(May 2016) 3 DRAFT FOR COMMENTS - WHO
Working document May 2016 . DRAFT document for comment 1. 2 GUIDELINES ON validation . 3 (May 2016 ). 4 DRAFT FOR COMMENTS . Should you have any COMMENTS on the attached text, please send these to Dr S. Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms with a copy to Ms Marie Gaspard by 12 July 2016 . Medicines Quality Assurance working documents will be sent out electronically only and will also be placed on the Medicines website for comment under Current projects . If you do not already receive our DRAFT working documents please let us have your email address (to and we will add it to our electronic mailing list. 5. 6 World Health Organization 2016 . 7 . All rights reserved. 8 This DRAFT is intended for a restricted audience only, the individuals and organizations having 9 received this DRAFT .)
122 manufacturing practices (GMP) (4) and good clinical practices (GCP). It is 123 therefore an element of the pharmaceutical quality system. Validation, as a ... Validation of specific processes and systems, for example, in 165 sterile product manufacture, requires much more consideration and a
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